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NeoGen

FDA UDI

Class II (US FDA UDI)

by Energist, Ltd.

Identity

Trade Name
NeoGen FDA UDI
Generic Name
Nitrogen plasma skin surface treatment system FDA UDI
Device Name
NeoGen 25mm 3x Nozzle (Grey) FDA UDI
Model / Reference
NeoGen 25mm 3x Nozzle (Grey) FDA UDI
Description
NeoGen 25mm 3x Nozzle (Grey) FDA UDI

Identifiers

Catalog Number
830-060 FDA UDI
Primary DI / UDI-DI
05060440520266 FDA UDI
510(k) Number
K132754 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Nitrogen plasma skin surface treatment system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4400 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Nitrogen plasma skin surface treatment system

NeoGen by Energist, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nitrogen plasma skin surface treatment system.

Cleared under the same submission

K132754 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Energist, Ltd.

Sources (1)

  • FDA UDI 5f8813de-0105-4fe0-995f-ab9ab2a7a46b 36 fields · synced May 30, 2026